Gemcitabine and Leflunomide for Advanced Pancreatic Cancer
This study is testing a combination of two drugs, gemcitabine and leflunomide, for people with advanced pancreatic cancer that cannot be removed by surgery. Gemcitabine is a common chemotherapy, and leflunomide, usually for rheumatoid arthritis, is being explored as a cancer treatment. Researchers want to find the safest and most effective dose of these drugs together. They will also look at how well the treatment works to slow cancer growth and improve quality of life. The study aims to enroll 19 participants and is currently unclear on its recruitment status.
- Study design
- This is a Phase Ib interventional study, meaning it's an early-stage trial focusing on safety and dosage. It plans to enroll 19 participants.
- What's involved
- You would receive gemcitabine through an IV and take leflunomide by mouth. You would also have blood samples taken and undergo CT scans or other imaging.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor side effects for up to 30 days after you finish study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06454383
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~19 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCholestyramineComputed TomographyDiagnostic ImagingGemcitabineLeflunomide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs)
Measured over Up to 28 days (cycle 1)
+1 more outcome measured
Conditions
NCT06454383
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope Medical Center
Duarte, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Vincent Chung · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative.
Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure oral medication compliance.
Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
If unavailable, exceptions may be granted with study principal investigator (PI) approval.
Age: ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) ≤ 1.
Subjects must have histologically or cytologically confirmed diagnosis of advanced unresectable pancreatic ductal adenocarcinoma (PDA).
Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Potential patients must have plans of receiving single agent gemcitabine.
Fully recovered from the acute toxic effects (except alopecia or neuropathy) to ≤ grade 1 to prior anti-cancer therapy.
Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement.
Without bone marrow involvement: Platelets ≥ 100,000/mm\^3 NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement.
Hemoglobin ≥ 9g/dL NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement.
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 x ULN (unless has Gilbert's disease total bilirubin ≤ 3 x ULN)
Aspartate aminotransferase (AST) ≤ 1.5 x ULN OR if liver metastases ≤ 3 x ULN
Alanine aminotransferase (ALT) ≤ 1.5 x ULN OR if liver metastases ≤ 2 x ULN
Creatinine ≤ 1.5 x ULN OR creatinine clearance (Cockcroft Gault) of ≥ 50 mL/min for participants with a creatinine level of \> 1.5 x ULN.
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of gemcitabine therapy for women and at least 3 months after the last dose of gemcitabine therapy for men, and/or undergo drug elimination of leflunomide at end of treatment until leflunomide is undetectable in the plasma.
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
Exclusion
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.
Drugs metabolized by CYP2C8, CYP1A2, BCRP, OATP1B1/B3, and OAT3 transporters within 21 days prior to day 1 of protocol therapy.
Herbal medications (excluding cannabidiol \[CBD\]).
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
Positive for tuberculosis or latent tuberculosis (TB).
Active diarrhea.
Clinically significant uncontrolled illness.
Active infection requiring antibiotics.
Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection. (\*If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.)
Diagnosis of Gilbert's disease.
Prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry. Other malignancies with low probability of recurrence may be allowed with PI approval.
Females only: Pregnant or breastfeeding.
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
What this trial measures
- Dose limiting toxicities (DLTs)Up to 28 days (cycle 1)
Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0.
- Incidence of adverse eventsUp to 30 days after completion of study treatment
Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0.